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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id1127
      • user_id263
      • trial_status_id5
      • abstract_of_study<p>\n Sickle cell disease (SCD) is a related group of common and rare hemoglobin (Hb) genotypes in which all affected individuals are either homozygotes for the sickle Hb (HbS) mutation of the β-globin subunit or compound heterozygotes for HbS and another globin gene mutation. A hallmark symptom of SCD is a painful Vaso-occlusive crisis (VOC). An interplay of the various pathologic processes in SCD perpetuates and feeds forward an inflammatory priming that, in the presence of a precipitating event, can lead to a VOC. VOCs are responsible for a wide variety of clinical complications of SCD, including pain syndromes, acute chest syndrome (ACS), stroke, priapism, leg ulcers, spontaneous abortion, renal insufficiency, and multiorgan failure leading to death. Frequency of VOCs, along with Absolute Neutrophil count (ACS), is the most common predictor of death in patients with SCD. Thus, early identification, treatment, and prevention of VOCs could significantly impact the natural course of the disease. Interventions for treatment and prevention of longer-term complications are urgently needed.</p>\n<p>\n  </p>\n<p>\n About 240,000 children in Africa, are born each year with Sickle Cell Disease (SCD), while here in Kenya, it is estimated that 6,000 children are born with the disease. Sadly, between 50 to 80 per cent of these children die before their fifth birthday. The recurrent pain and complications caused by the disease, can interfere with many aspects of the patient’s life, including education, employment and psychosocial development.</p>\n
      • study_title<p align=\"center\">\n <strong>A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Characterize the Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients with Sickle Cell Disease</strong></p>\n
      • laymans_summary<p>\n The objective of this study is to understand/characterize the pharmacokinetic/PK (how our bodies affect the drug) and the Pharmacodynamics/PD (meaning how the drug affects our bodies) of a drug called Rifaximin, which is used in treatment of patients with sickle cell disease.</p>\n<p>\n Of the current treatment options available for sickle cell disease, only bone marrow transplant is a permanent cure, but few patients qualify for this treatment. Patients on the other treatment options e.g., hydroxyurea and L glutamine may still experience acute clogging of blood vessels called Vaso Occlusive crisis (VOC) There is a need to find more treatment options for sickle cell disease that prevents the VOC.</p>\n
      • short_titleSickle Cell Disease
      • protocol_noECCT/22/03/06
      • version_noVersion 2.0_16 Aug 2021
      • date_of_protocol16-08-2021
      • study_drugrifaximin ER and DER
      • disease_conditionSickle cell disease
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_namexifaxan
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
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      • applicant_participating_countries(null)
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantMichelle Botha
      • declaration_date120-03-2022
      • declaration_principal_investigatorDr L Tina
      • declaration_date220-03-2022
      • placebo_presentYes
      • study_objectives<p>\n The objectives of this study are: To characterize the pharmacokinetics/pharmacodynamics (PK/PD) of rifaximin ER and DER in subjects with sickle cell disease (SCD) and to assess the safety and tolerability of rifaximin (Extended Release) ER and Delayed Extended Release (DER).</p>\n
      • principal_inclusion_criteria<p>\n Participants are eligible for the study only if all the following criteria are met:</p>\n<ol>\n <li>\n Subject must have the ability and willingness to sign a written informed consent form.</li>\n <li>\n Subject is between the ages of 18 to 70 years old (inclusive) at the time of consent.</li>\n <li>\n Subject has SCD of any genotype (HbSS, HbSC, HbS β-thalassemia). If the subject’s genotype has not been previously documented, genotyping will be performed during Screening using high-performance liquid chromatography (HPLC)/electrophoresis.</li>\n <li value=\"4\">\n Subject must have experienced at least 2 VOCs within the 12 months prior to Screening. A VOC is defined as: </li>\n</ol>\n<p>\n                             a. The occurrence of appropriate symptoms consistent with a painful crisis, acute chest syndrome (ACS), or priapism, and</p>\n<p style=\"margin-left: 72pt;\">\n b. Requires a visit to a medical facility and/or healthcare professional, and</p>\n<p style=\"margin-left: 72pt;\">\n c. Receipt of either a parenteral or oral opioid or NSAID analgesia.</p>\n<ol>\n <li value=\"5\">\n If subject is receiving hydroxyurea (HU)/hydroxycarbamide (HC), subject must have been receiving the treatment for at least 6 months prior to Screening and must agree to maintain the same dose and schedule for the duration of the study.</li>\n <li value=\"6\">\n Subjects must have laboratory values at Screening within the following ranges:\n <ul>\n <li>\n Absolute Neutrophil Count ≥1.0 x 109/L</li>\n <li>\n Platelets ≥ 75 x 109/L</li>\n <li>\n Hemoglobin (Hgb) ≥ 6.0 g/dL</li>\n <li>\n Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m2 using the CKD-EPI formula</li>\n <li>\n Direct (conjugated) bilirubin ≤ 2.0 x ULN</li>\n <li>\n Alanine transaminase (ALT) ≤ 3.0 x ULN</li>\n <li>\n International Normalized Ratio (INR) ≤ 2.0</li>\n </ul>\n </li>\n <li value=\"7\">\n Eastern Cooperate Oncology Group (ECOG) performance status ≤ 2.</li>\n <li value=\"8\">\n Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at Screening and agree to use standard prevention methods for the duration of the study.</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Participants are not eligible for inclusion for the trial if any of the following criteria are met:</p>\n<ol>\n <li>\n Subject is receiving concomitant treatment with voxelotor, crizanlizumab, or L-glutamine.</li>\n <li>\n Subject has any history of stem cell transplant is planning to begin or has received in the past 30 days.</li>\n <li value=\"3\">\n Subject experiences an acute VOC, requiring a visit to a medical facility and/or healthcare professional, ending within 7 days prior to Day 1 dosing.</li>\n <li value=\"4\">\n Subject has received any blood products within 30 days of Day 1 dosing.</li>\n <li value=\"5\">\n Subject has uncontrolled liver disease or renal impairment, ulcerative colitis, Crohn’s disease, or other chronic GI disorder.</li>\n <li value=\"6\">\n Subject has received active treatment in another investigational trial within 30 days or 5 half-lives of the last dose of the investigational agent, whichever is greater, prior to Screening.</li>\n <li value=\"7\">\n Subject has received penicillin prophylaxis or antibiotics for treatment of infection within 30 days or 5 half-lives of the treatment, whichever is greater, prior to Screening.</li>\n <li value=\"8\">\n Subject has a significant medical condition that required hospitalization (other than for a VOC) within 2 months prior to Screening.</li>\n <li value=\"9\">\n Subject is planning on undergoing an exchange transfusion during the duration of the study or has completed one within 4 weeks prior to Day 1 dosing.</li>\n <li value=\"10\">\n Subject has a hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any components of rifaximin ER and DER.</li>\n <li value=\"11\">\n Subject has used therapeutic anticoagulation (prophylactic doses are permitted) or antiplatelet therapy (other than aspirin or NSAIDs) within 10 days prior to Day 1 dosing.</li>\n <li value=\"12\">\n Subject is pregnant or a nursing woman.</li>\n <li value=\"13\">\n Subject has a history of illicit drug use or abuse, either documented or in the opinion of the Investigator.</li>\n <li value=\"14\">\n Subject is using any medication that is known to inhibit or induce CYP3A4, P-gp, or OATP1B1/B3 (See Appendix 3) within 30 days or 5 half-lives, whichever is longer, prior to Day 1 dosing, or in the opinion of the Investigator, may affect the evaluation of the study product or place the subject at undue risk.</li>\n <li value=\"15\">\n Subject has had any prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach, or small/large intestine (with the exception of appendectomy, cholecystectomy, and fundoplication).</li>\n <li value=\"16\">\n Subject has had a colonoscopy or sigmoidoscopy within 30 days prior to Day 1 or plans to undergo such a procedure during the duration of the study.</li>\n <li value=\"17\">\n Subject has used bowel prep, laxative, or enema within 30 days prior to Day 1.</li>\n <li value=\"18\">\n Subject has a bleeding disorder including, but not limited to, acquired or congenital platelet function defects, disseminated intravascular coagulation (DIC), bleeding factor deficiencies, hemophilia, idiopathic thrombocytopenia purpura (ITP), or von Willebrand’s disease.</li>\n <li value=\"19\">\n Subject is planning to undergo a major surgical procedure during the duration of the study.</li>\n <li value=\"20\">\n Subject has a positive test for human immunodeficiency virus (HIV)1 or HIV2.</li>\n <li value=\"21\">\n Subject has an active Hepatitis B infection (HBsAg positive). Prior infection that is not active (i.e., HBsAg negative, HBcAb positive, and HBsAb positive) is permitted.</li>\n <li value=\"22\">\n Subject has a positive test for Hepatitis C (HCV RNA). Prior infection with spontaneous resolution or sustained resolution for ≥ 24 weeks after cessation of antivirals is permitted.</li>\n <li value=\"23\">\n Subject has an active COVID-19 infection or complication(s) related to COVID-19 infection that are unresolved or, in the opinion of the Investigator, may affect evaluation of the study drug or place the subject at undue risk.</li>\n <li value=\"24\">\n Subjects has received a vaccine (including COVID-19 vaccine) within 2 weeks prior to Screening. If subject has received their first of two COVID-19 vaccination doses, as applicable, they must wait for at least 2 weeks after receiving the second dose, and be symptom-free, prior to beginning Screening. Subject must not be planning for COVID-19 or other vaccinations while on study.</li>\n <li value=\"25\">\n Subject has a malignant disease. Exceptions include malignancies that were treated curatively and have not recurred within 2 years prior to study treatment, completely resected basal cell and squamous cell skin cancers, and any completely resected carcinoma in situ.</li>\n <li value=\"26\">\n Subjects has prolonged QT interval as assessed by ECG history within the past 3 months. For subjects with no historical ECG information, subject has a resting QTcF ≥ 460 msec for males and ≥ 470 msec for females at Screening.</li>\n <li value=\"27\">\n Subject has any unstable cardiac condition that, in the opinion of the Investigator, may worsen during the study or interfere with successful evaluation of the study treatment.</li>\n <li value=\"28\">\n Subject has a serious mental or physical illness which, in the opinion of the Investigator, would compromise participation in the study.</li>\n <li value=\"29\">\n Subject has any condition which, in the opinion of the Investigator, is likely to interfere with the successful collection of the measurements required for the study.</li>\n</ol>\n
      • primary_end_points<p>\n Full rifaximin and 25-desacetyl rifaximin plasma PK profiles following administration on Days 1 and 29 and C_max and C_trough on Days 8, 15, and 29 will be evaluated at specified timepoints according to the schedule of activities.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 1. Victoria Biomedical Research Institute (VIBRI) (PI:  LO Tina):</p>\n<p>\n VIBRI is a non-profit providing pharmaceutical, academic research and non-profit organization with a network of clinical sites and expertise focusing on accelerating transformative therapeutics, vaccines, and devices research for major gloabl health diseases in Kenya.  VIBRI is located at the Kisumu County Referral Hospital in Kisumu County, western Kenya.  VIBRI was established to conduct biomedical research including clinical trials, bioequivalence studies, basic science research studies, epidemiology and population health studies, implementation science studies, build a strong doundation in data science, conduct training and capacity building on clinical research in Kenya.  VIBRI has experienced and accomplished clinical research scientists who have designed and conducted GCP compliance phase 1b to phase IV paediatric and adult clinical trials.  </p>\n<p>\n 2. CREATES (PI:  Dr Bernhards Ogutu):</p>\n<p>\n The KUTRH is designed for clinical trials with a bed space of 600 and ICU beds of 25.  It is a referral healthcare facility experienced in clinical trials. The PI is support by a large team of experienced Sub Investigators and SSCs.  Along with experienced pharmacists to manage the IP.  The site has ample well-equipped clinical laboratories, radiological services and ample clinical observation areas as well as spacious research operations office.</p>\n<p>\n 3. International Cancer Institute (PI:  Prof. FC Asirwa):</p>\n<p align=\"left\" style=\"margin-left:.45pt;\">\n The study will be conducted at the International Cancer Institute (ICI) in Eldoret, Kenya. Recruitment will occur at the research and care clinic located along Nandi Road. ICI research and care clinic is staffed by qualified research personnel including 1 Medical Oncologist, 1 Clinical Oncologist, 4 medical officers, 1 Pharmacist, 1 pharmaceutical Technologist, 1 clinical officer, 4 nurses,1 consultant pathologist, 2 laboratory technologists, 1 patient navigator and 1 administrator. ICI has a research and molecular diagnostics laboratory, for sample testing and storage. The site has a registration area, consultation rooms, examination rooms, chemotherapy administration area, records and data storage, pharmacy and laboratory. International Cancer Institute currently runs a clinic where patients with SCD from Uasin Gishu County and different parts of the Country are managed. The site participates in several other Randomized controlled trials with key focus on Haemato-oncology trials.</p>\n<p>\n 4. KEMRI/USAMRD-K Kombewa Clinical Research Center (PI: Janet Oyieko)</p>\n<div>\n The KEMRI/WRP Kombewa Clinical Research Center (KCRC) is designed for large clinical</div>\n<div>\n trials and has a full clinical laboratory including microbiology capability.</div>\n<div>\n KCRC is part of The Walter Reed Project (WRP), which is a 40-year collaboration between the</div>\n<div>\n Kenya Medical Research Institute, (KEMRI) and the Walter Reed Army Institute of Research</div>\n<div>\n (WRAIR). The US Army Medical Research Unit in Kenya (USAMRU-K) is a WRAIR</div>\n<div>\n attachment stationed in Kenya with headquarters in Nairobi and field stations in Kericho and</div>\n<div>\n Kisumu. WRP-Kisumu conducts a wide spectrum of field and laboratory work including</div>\n<div>\n numerous clinical research trials.</div>\n
      • other_details_explanation<p>\n Study is being conducted in America</p>\n
      • other_details_regulatory_notapproved<p>\n Applications are planned for Egypt and Lebanon</p>\n
      • other_details_regulatory_approved<p>\n US FDA provided approval to proceed on 11 June 2021</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration6 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites4
      • multi_country_listNorth America\nMiddle east
      • data_monitoring_committeeNo
      • total_enrolment_per_site3-10
      • total_participants_worldwide60
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLucas
      • investigator1_middle_nameOtieno
      • investigator1_family_nameTina
      • investigator1_qualificationMBChB, MSc, DLSHTM
      • investigator1_professional_addressVictoria Biomedical Research Institute
      • investigator1_telephone+254720596654
      • investigator1_emaillucas.tina0818@gamil.com
      • organisations_transferred_Yes
      • number_participants20
      • notification
      • approval_date15-09-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-05-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer comments have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-06-11 12:33:58
      • created2022-03-09 10:16:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id799
        • application_id1127
        • given_nameJanet
        • middle_name
        • family_nameOyieko
        • qualificationMBChB, MMED, PhD
        • professional_addressKombewa Clinical Research Centre
        • telephone+254721996988
        • emailjanet.oyieko@gmail.com
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
      • 1(array)
        • id800
        • application_id1127
        • given_nameFredrick
        • middle_nameChite
        • family_nameAsirwa
        • qualificationProf, M.D.
        • professional_addressInternational Cancer Institute (ICI).
        • telephone+254 718 473 446
        • emaildirector@intercancer.com
        • created2022-03-11 10:09:31
        • modified2022-05-09 16:38:41
      • 2(array)
        • id801
        • application_id1127
        • given_nameBernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MSc
        • professional_addressCREATES - Strathmore University Medical Centre
        • telephone+254733812613
        • emailogutu6@gmail.com
        • created2022-03-11 10:09:31
        • modified2022-05-09 16:38:41
    • SiteDetail(array)
      • 0(array)
        • id1253
        • application_id1127
        • county_id42
        • site_nameKombewa Clinical Research Centre
        • physical_addressOff Kisumu-Bondo Road, opposite Kombewa county Hospital
        • contact_details+254721996988
        • contact_personDr. Janet Oyieko
        • site_capacity(null)
        • misc(null)
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1254
        • application_id1127
        • county_id42
        • site_nameVictoria Biomedical Research institute
        • physical_addressP.O BOX 7180-40100 KISUMU
        • contact_details+254720597654
        • contact_personDr. Lucas Otieno tina
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1255
        • application_id1127
        • county_id27
        • site_nameInternational Cancer Centre
        • physical_addressNandi road, P.O BOX 8088, Eldoret
        • contact_details+254700522149
        • contact_personDr. Fredrick Asirwa
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 3(array)
        • id1256
        • application_id1127
        • county_id47
        • site_nameCREATES - Strathmore University Medical Centre
        • physical_addressP.O BOX 59857 - 00200 Madaraka Estate, Nairobi
        • contact_details+254733812613
        • contact_personDr. Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id583
        • application_id1127
        • sponsorSalix Pharmaceuticals, Inc., a division of Bausch Health US, LLC.
        • sponsor_typeIndustry
        • contact_person
        • addressBausch Health US, LLC Bridgewater, NJ 08807 USA
        • telephone_number1-800-321-4576
        • fax_number
        • cell_number 908-927-1400
        • email_addressSean.Humphrey@bauschhealth.com
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
  • 1(array)
    • Application(array)
      • id1388
      • user_id613
      • trial_status_id6
      • abstract_of_study<p>\n Multidrug resistant TB (MDR TB) has been on the rise worldwide with WHO estimating that there were 480000 cases worldwide in the year 2015. MDR TB is of global significance due to associated high mortality rates and toxicity associated with drugs used for treatment. Therefore, there is need to prevent contacts of index cases from contracting the disease</p>\n<p>\n A5300B is a Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same HH are a cluster) to compare the efficacy and safety of 26 weeks of DLM versus 26 weeks of INH for preventing confirmed or probable active TB during 96 weeks of follow-up among HIV-infected and other high-risk HHCs of adults with MDR-TB (index case).</p>\n<p>\n The study will enroll adults (≥18 years) with MDR TB and their house hold contacts. Index case is defined as patient with confirmed rifampicin and isoniazid resistance. House hold contacts are individuals who currently lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the index case and who report exposure within 90 days prior to index case starting MDR –TB treatment. The house hold contacts are children aged < 5years of age or adults, adolescents and children aged above 5 years who are LTBI positive.</p>\n<p>\n  </p>\n<p>\n Globally, a target of 5610 participants will be enrolled (1726 index cases and 3452 contacts) and each participant will remain in the study for a period of 96 weeks. Kericho site anticipates to screen 100 potential index cases to enroll 70 index cases and 280 contacts</p>\n
      • study_title<p align=\"center\">\n <strong><u>P</u></strong><strong>rotecting <u>H</u>ouseholds <u>O</u>n <u>E</u>xposure to <u>N</u>ewly Diagnosed <u>I</u>nde<u>x</u> Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)</strong></p>\n
      • laymans_summary<p>\n <strong>Title: </strong>Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)</p>\n<p>\n <strong>Lay title</strong>: A study comparing the safety and efficacy of two drugs for preventing confirmed or probable active TB among house hold contacts of patients with MDR-TB.</p>\n<p>\n A Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same household [HH] are a cluster), to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.</p>\n<p>\n Approximately 5610 (2158 index cases and 3452 household contacts) will be enrolled into the study globally. The Kericho site anticipates to enroll up to 350 participants</p>\n
      • short_titlePHOENIx MDR-TB)
      • protocol_noECCT/24/03/06
      • version_no4.0
      • date_of_protocol30-11-2022
      • study_drugdelamanid
      • disease_conditionMDR TB
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDelamanid
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameStandard of care Isoniazid
      • comparator_registeredyes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressKericho.DRS@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Lucy Koech
      • declaration_date113-03-2024
      • declaration_principal_investigatorDr Lucy Koech
      • declaration_date213-03-2024
      • placebo_presentNo
      • study_objectives<h3>\n To compare the efficacy of 26 weeks of DLM versus 26 weeks of INH for preventing confirmed or probable active TB during 96 weeks of follow-up.</h3>\n<p>\n  </p>\n<h3>\n To compare the safety (permanently stopping study drug due to treatment-related adverse events) of 26 weeks of DLM versus 26 weeks of INH for the treatment of presumed latent TB infection (LTBI) with MDR-TB.</h3>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n  </div>\n<div>\n Started MDR-TB treatment within the past 90 days.</div>\n<div>\n Ability and willingness of the index case to provide informed consent to access</div>\n<div>\n the HH and approach HH members for evaluation</div>\n<div>\n Men and women age ≥18 years</div>\n
      • principal_exclusion_criteria<div>\n Has previously enrolled into the A5300B/I2003B/PHOENIx trial as an index case</div>\n<div>\n or HHC, or is a member of a HH which has previously enrolled into the</div>\n<div>\n A5300B/I2003B/PHOENIx trial.</div>\n<div>\n  </div>\n
      • primary_end_points<p>\n <em>The study endpoints are detailed in the parent protocol pages 72-83.</em></p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 3
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n PhD - 1</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n MMED - 2</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n MSc - 10</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n BSc - 20</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Diploma - 50</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n CAP Certified Laboratory</p>\n
      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n WRAIR and KEMRI SERU</p>\n
      • other_details_regulatory_approved<p>\n Awaiting KEMRI/SERU approval</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_durationParticipant followed up for 96 Weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorISONIAZID
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_statesAfrica. ASIA, South America
      • number_of_sites2
      • multi_country_listKenya, South Africa, Malawi, Botswana, Uganda, Peru, Haiti, Vietnam and Tanzania
      • data_monitoring_committeeYes
      • total_enrolment_per_site350
      • total_participants_worldwide5610
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Fredrick Sawe
      • investigator1_middle_name
      • investigator1_family_nameSAWE
      • investigator1_qualification MBChB, MMED
      • investigator1_professional_addressKenya Medical Research Institute/Walter Reed Project P.O Box 1357 – 20200,
      • investigator1_telephone+254 703247902
      • investigator1_emailFredrick.sawe@usamru-k.org
      • organisations_transferred_No
      • number_participants350
      • notification
      • approval_date21-05-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-05-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted07-05-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed and approved by two (2) reviewers.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-24 14:01:30
      • created2024-03-13 08:59:16
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1048
        • application_id1388
        • given_nameDr Lucy Chepkurui Koech
        • middle_name
        • family_nameKOECH
        • qualificationMBChB
        • professional_addressKenya Medical Research Institute/Walter Reed Project P.O Box 1357 – 20200,
        • telephone+254 719193275
        • emailLucy.koech@usamru-k.org
        • created2024-03-13 10:10:19
        • modified2024-05-17 12:46:39
    • SiteDetail(array)
      • 0(array)
        • id1684
        • application_id1388
        • county_id35
        • site_nameKenya medical Research Institute/ Walter Reed Project
        • physical_addressOFF Hospital Road
        • contact_detailsP.O. BOX 1357 Kericho
        • contact_personDr Lucy C. Koech
        • site_capacity(null)
        • misc(null)
        • created2024-03-13 10:10:19
        • modified2024-05-17 12:46:39
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id1712
        • application_id1388
        • county_id27
        • site_nameMoi university clinic research Centre
        • physical_addressAmpath Centre at MTRH
        • contact_detailsP.O.BOX 4604 Eldoret
        • contact_personDr Abraham Mosigisi Siika
        • site_capacity(null)
        • misc(null)
        • created2024-05-17 11:11:31
        • modified2024-05-17 12:46:39
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id732
        • application_id1388
        • sponsorNational Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development
        • sponsor_typeResearch Institution
        • contact_person
        • addressACTGIMPAACT.COREPHOENIX@fstrf.org
        • telephone_number301-897-1707.
        • fax_number
        • cell_number301-897-1707.
        • email_addressACTGIMPAACT.COREPHOENIX@fstrf.org
        • created2024-03-13 10:10:19
        • modified2024-05-17 12:46:39
  • 2(array)
    • Application(array)
      • id612
      • user_id94
      • trial_status_id8
      • abstract_of_study<p>\n Current WHO-recommended treatment for Visceral Leishmaniasis (VL) in Eastern Africa is a combination of Sodium Stibogluconate (SSG) and paromomycin (PM) administered for 17 days, with an efficacy of 91%. This treatment is far from optimal as it requires 17 days of two separate painful injections, necessitating patients to be hospitalized during the whole treatment period. In addition, the antimonial SSG exhibits life-threatening toxicities such as cardiotoxicity, hepatotoxicity and pancreatitis. Therefore, there is an urgent need to explore alternatives that are efficacious, safe, ideally of short duration, affordable and suitable to be used in remote areas where VL occurs.</p>\n<p>\n Until new chemical entities are developped, opportunities with currently available compounds should be assessed to improve on current treatment options, with the main aim to replace the toxic and patient-unfriendly SSG treatment-component.</p>\n<p>\n Miltefosine (MF) is the only oral drug available for VL treatment. It has been extensively used in Asia for VL treatment as monotherapy for 28 days, with satisfactory cure rates (>90%). However, MF as monotherapy showed lower efficacy in Eastern Africa (72%, 95%CI: 60–85%) than in Asia. PK data indicated under-exposure and higher relapse rates in children compared to adults with the conventional linear 2.5 mg/kg/day MF dose. To overcome this under-dosage in children, an allometrically scaled dosing regimen has been developed. This allometric dosage was assessed for paediatric VL in the LEAP 0714 trial in Kenya and Uganda. The 28 days regimen of MF allometric dose showed a cure rate of 90.0% (95% CI: 73.5-97.9%) at 6 months follow up in a population of 30 patients aged 4 to 12 years. These results showed that the efficacy level could be increased in children treated with the allometric dose, reaching similar efficacy observed in adults (i.e. 86.2%). </p>\n<p>\n PM has been well studied in Eastern Africa during the development of the combination SSG-PM. PM monotherapy of 20mg/kg/d IM for 21 days showed an overall efficacy at 6 months of 84.3%. Intramuscular PM can be administered at primary health care level, requires minimal training of health personnel and the drug can be stored at room temperature.</p>\n<p>\n Replacing the toxic SSG with oral MF can bring better safety and a more field-adapted, patient-friendly treatment.</p>\n<p>\n The current study aims to determine the safety and efficacy of two combination regimens of PM and MF as compared to SSG-PM for the treatment of primary VL patients in Eastern Africa.  This will be an open label, Phase III, randomized controlled, parallel arm multicentre non-inferiority clinical trial. The study treatments are:</p>\n<ul>\n <li>\n Arm 1: Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric dosing BID for 14 days</li>\n <li>\n Arm 2: Paromomycin 20 mg/kg/d IM for 14 days combined with oral miltefosine allometric dosing BID for 28 days</li>\n</ul>\n<p>\n The control arm is the current standard treatment for VL in East Africa:</p>\n<ul>\n <li>\n Arm 3: Sodium Stibogluconate 20 mg/kg/day IM/IV combined with Paromomycin 15 mg/kg/day IM for 17 days</li>\n</ul>\n<p>\n MF allometric dosing will be calculated according to patient’s weight, height and sex. For patients weighing < 30 kg, an easy-to-use table with allometric dosing scheme by weight, height and sex will be provided to the investigators to define the exact daily dose to be administered. For patients weighing ≥ 30 kg, the allometric dose will correspond to the conventional dose in mg/kg. Therefore, patients weighing ≥ 30 to 44 kg will receive 100 mg/day and patients ≥ 45 kg will receive 150 mg/day.</p>\n<p>\n Subjects will be hospitalized for 14 days of PM and MF treatment in both arm 1 and arm 2.  MF treatment will start at the same time as PM treatment. At discharge (on day 15), patients allocated to arm 2 will be instructed to continue MF treatment on an out-patient basis until completion of the 28 days treatment. Subjects will receive clear instructions as well as a daily diary to guide them in their treatment schedule at home.</p>\n<p>\n SSG-PM combination therapy will be administered for 17 days according to routine VL treatment guidelines and patients will remain hospitalized for the entire duration of the treatment.</p>\n<p>\n The target population will be primary VL patients from 4 to 50 years. It is important to include a paediatric population which is particularly vulnerable and is a major factor in the East African disease burden. The trial will be run in the VL endemic countries at 6 LEAP sites: Kimalel and Kacheliba in Kenya, Amudat in Uganda, Doka and Um El Kher in Sudan and Gondar in Ethiopia.  </p>\n<p>\n Enrollment targe is 576 patients, 192 in each arm. Each patient’s participation in the study will be for approximately 7 months. This will consist of baseline assessments, treatment period (14, 17 or 28 days) and 6 months follow-up. Recruitment for the entire trial is expected to take 14 to 17 months assuming that 30 to 35% of all VL patients will meet the eligibility criteria. Therefore, study duration (first patient in to last patient, last visit) is expected to take approximately 24 months. Taking into account the analysis and reporting period, the study shall last at most 31 months.</p>\n<p>\n Primary efficacy endpoint will be the cure at day 210, based on clinical examination only (absence of clinical signs and symptoms of VL and no requirement for rescue treatment during the trial).</p>\n<p>\n Safety assessments will be done through routine monitoring of adverse events. A characterization of the nature and frequency of SAEs, AEs that lead to treatment discontinuation and overall frequency and severity of AEs from start of the treatment until 6 months follow-up will be made.</p>\n<p>\n Pharmacokinetics (PK) profile of PM and MF will be described and parasite clearance in each arm as indicated by direct microscopy and quantitative polymerase chain reaction (qPCR) will be evaluated as pharmacodynamics (PD) markers of cure. The relationship between PK and PD measurements will be further assessed through drug exposure-response modelling.</p>\n<p>\n Finally, compliance to MF treatment in an outpatient setting will also be assessed. If proven non-inferior to SSG-PM, the combination of PM and MF is expected to improve significantly treatment safety and to reduce pain, while ensuring low cost and suitability to be used in remote areas. It will provide the East African region with the first non-antimony-based effective treatment for VL.</p>\n
      • study_title<p align=\"center\">\n <span style=\"font-size:14px;\"><strong>An Open </strong><strong>Label</strong><strong>, Phase III, Randomized Controlled, </strong><strong>Multicentre</strong><strong> Non-Inferiority Trial </strong><strong>to</strong><strong> Compare Efficacy and Safety </strong><strong>of Miltefosine and </strong><strong>Paromomycin with Sodium Stibogluconate and Paromomycin Combination for Treatment </strong><strong>of</strong><strong> Primary Visceral Leishmaniasis (VL) Patients </strong><strong>in</strong><strong> Eastern </strong><strong>Africa</strong></span></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n  </p>\n<p align=\"center\">\n <strong><u>LAY SUMMARY OF PROTOCOL FOR SERU SUBMISSION</u></strong></p>\n<p align=\"center\">\n  </p>\n<p>\n <strong>Protocol Title:</strong> An open-label, Phase lll, randomized controlled multicenter non-inferiority trial to compare efficacy and safety of Miltefosine and paromomycin with sodium stibogluconate and Paromomycin combination for treatment of primary visceral leishmaniasis patients in Eastern Africa</p>\n<p>\n <strong>Institutions and Investigators:</strong></p>\n<ol>\n <li>\n Kenya Medical Research Institute - Dr. Jane Mbui, Dr. Simon Njenga</li>\n <li>\n Kimalel Health Centre: Dr. Peter Kioko</li>\n <li>\n Kacheliba Sub-District Hospital: Mark Riongoita</li>\n</ol>\n<p>\n  </p>\n<p>\n <strong>Sponsor</strong>: Drugs for Neglected Diseases <em>initiative</em> (DNDi), 15 Chemin Louis Dunant, 1202 Geneva, Switzerland</p>\n<p>\n <strong>Protocol Summary:</strong></p>\n<p>\n The current treatment for Kala-azar in East Africa is Sodium Stibogluconate (SSG) with Paromomycin (PM) for 17 days. This treatment requires 2 injections every day for 17 days in the hospital. The injections are painful and can affect the heart, liver, and pancreas. This study is being done to find better treatments that take fewer days, are effective, safer, less painful, affordable and easy for use in remote areas.</p>\n<p>\n This study aims to determine the safety and efficacy (how well a treatment works) of two combination regimens of PM and Miltefosine (MF) as compared to SSG-PM for the treatment of Kala-azar in patients in Eastern Africa.  Miltefosine is taken by mouth while SSG and PM are given by injection.</p>\n<p>\n There will be three treatment groups. Two groups will receive PM+MF combination for 14 days with one of them extending MF until 28 days. A third group will receive SSG and PM combination for 17 days.</p>\n<ul>\n <li>\n Group 1: Paromomycin injection for 14 days combined with Miltefosine by mouth 2 times a day for 14 days</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n Group 2: Paromomycin injection for 14 days combined with Miltefosine by mouth 2 times  a day for 28 days</li>\n</ul>\n<ul>\n <li>\n Group 3: Sodium Stibogluconate injection combined with Paromomycin injection for 17 days\n <ul style=\"list-style-type:circle;\">\n <li>\n <em>Note: Group 3 is called the control group</em> – it is the current standard treatment for Kala-azar in East Africa</li>\n </ul>\n </li>\n</ul>\n<p>\n  </p>\n<p>\n In this study each patient’s treatment will be allocated randomly by chance, equally between the 3 treatment groups being tested and each patient will know what treatment they will receive.</p>\n<p>\n All patients will get the treatments in the hospital except patients in the group receiving Miltefosine for 28 days who will take the remaining medicines at home after they are discharged when they finish their PM and MF for 14 days.</p>\n<p>\n The study will allow us to compare how the treatments work, know which PM and MF combination is better, how safe the treatments are and how regularly patients take the medicines at home.</p>\n<p>\n <strong>Study population and duration of the study</strong></p>\n<p>\n The target population for this study is patients who are being diagnosed with Kala-azar for the first time and who have never been treated for Kala-azar. These patients will range from 4 to 50 years old. It is important to include children in this study because they are particularly at risk of this disease and contribute to the disease burden in the Eastern African region.</p>\n<p>\n The study will enroll a total of 576 patients in Kenya, Sudan, Ethiopia and Uganda where Kala-azar affects the population. Each of the 3 treatment groups will have 192 patients. There are 6 hospitals involved in the study: Kimalel, and Kacheliba in Kenya; Amudat in Uganda; Gondar in Ethiopia and Dooka and Um El Kheir in Sudan. Participation for each patient in the study will be around 7 months from the day of enrollment until the last study visit. The study itself will last about 2 years from the first patient enrolled until the last patient has finished their last visit and the study is closed.</p>\n<p>\n <strong>Procedures during the study</strong></p>\n<p>\n Each study participant will stay in the hospital for about 2-3 weeks depending on their treatment group. During study participation, the patient will have assessments done before starting the study medication, followed by the treatment period of either 14, 17 or 28 days and 6 months of follow up after completing treatment. During the treatment period, patients will be seen in the clinic on Day 1, 3, 7, 14. Some patients in treatment group 2 will also be seen on day 21 to check the amount of Paramomycin in their blood. After discharge patients will come for follow up visits from home, 28 days after treatment start, 1 month after treatment start and at 6 months after the end of treatment.</p>\n<p>\n The health care workers will closely monitor the safety of the patients throughout the study by checking for any medical illness or any reactions that may or may not be related to the study treatments. If deemed necessary, treatment may be interrupted to ensure the safety of the patient. All safety events will be recorded, followed closely and treated appropriately for resolution of the event.</p>\n<p>\n Patients will have blood collected for measurement of the levels of the Miltefosine in their blood on day 28 and day 56 in order to assess if they have taken their drugs consistently and correctly as recommended.</p>\n<p>\n In Kenya and Sudan, 40 patients (20 children and 20 adults) in treatment groups 1 and 2 will have blood collected for measurement of drug (MF and PM) levels more frequently during the treatment period.</p>\n<p>\n The amount of parasite in the blood and bone marrow or spleen will be checked to assess how well the different treatments work and compare the response with the different treatments. The amount of parasite will also be checked in the follow up period if it is suspected that the patient has had a relapse of disease.</p>\n<p>\n Finally, adherence to MF treatment in an outpatient setting will also be assessed. If it is proven that MF and PM combination works as well as the combination of SSG and PM, the combination of PM and MF is expected to significantly improve treatment safety and to reduce pain, while ensuring low cost and suitability to be used in remote areas.</p>\n
      • short_titleMF/PM Phase III
      • protocol_noECCT/17/06/01
      • version_no1.0
      • date_of_protocol20-02-2017
      • study_drugMiltefosine (Impavido), Paromomycin, Sodium Stibogluconate
      • disease_conditionPrimary Visceral Leishmaniasis
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameMiltefosine, Paromomycin, Sodium Stibogluconate
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjmalongo@dndi.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
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      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
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      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
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      • applicant_complete_form(null)
      • applicant_impd0
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      • applicant_stability_data1
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      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGina Ouattara
      • declaration_date116-06-2017
      • declaration_principal_investigatorJane Mbui
      • declaration_date216-06-2017
      • placebo_presentNo
      • study_objectives<p>\n <br />\n Objectives<br />\n Primary Objective<br />\n • To compare the efficacy of two combination regimens of PM (14 days) and MF (14 or 28 days) with the standard 17-day course of SSG-PM for the treatment of primary VL patients in Eastern Africa<br />\n Secondary Objectives<br />\n • To compare the safety of two combination regimens of PM (14 days) and MF (14 or 28 days) with the standard 17-day course of SSG-PM<br />\n • To describe the pharmacokinetic (PK) profiles of PM and MF (14 days and 28 days regimen) in primary VL patients<br />\n • To evaluate parasite clearance in each arm as indicated by direct microscopy and quantitative polymerase chain reaction (qPCR)<br />\n • To assess the relationship between PK and PD measurements (parasitological and clinical outcome)<br />\n • To assess compliance to MF treatment in an outpatient setting</p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis</li>\n <li>\n Patients aged 4 to <u><</u> 50 years who are able to comply with the study protocol.</li>\n <li>\n Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for patients under 18 years of age. In the case of minors, assent from the children also needs to be obtained as per each country regulatory requirements</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Patients who are relapse cases</li>\n <li>\n Patients with Para-Kala azar dermal leishmaniasis</li>\n <li>\n Patients who have received any anti-leishmanial drugs in the last 6 months</li>\n <li>\n Patients with severe malnutrition (for children aged <5 years: weight-for-height WHO reference curves by sex, z score <-3; for children 5-18 years: BMI-for-age WHO reference curves by sex, z score < -3; for adults >18 years: BMI < 16)</li>\n <li>\n Patients with positive HIV diagnosis</li>\n <li>\n Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments</li>\n <li>\n Patients with previous history of cardiac arrhythmia or with a clinically significant abnormal ECG</li>\n <li>\n Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient’s response to study medication</li>\n <li>\n Patients suffering from other conditions associated with splenomegaly such as schistosomiasis</li>\n <li>\n Pregnant or lactating women</li>\n <li>\n Female patients of child bearing age who do not accept to have a pregnancy test done at screening and/or who do not agree to use contraception from treatment period until 5 months after the end of treatment (see section 15.2)</li>\n <li>\n Patients with haemoglobin < 5g/dl</li>\n <li>\n Patients with WBC < 1 x 10³/mm³</li>\n <li>\n Patients with platelets < 40,000/mm³</li>\n <li>\n Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range</li>\n <li>\n Patients with total bilirubin more than 1.5 times the upper normal range</li>\n <li>\n Patients with serum creatinine above the ULN for age and sex</li>\n <li>\n Patients with clinical signs of severe VL disease such as jaundice and bleeding</li>\n <li>\n Patients with pre-existing clinical hearing loss based on audiometry at baseline</li>\n <li>\n Patients who cannot comply with the planned scheduled visits and procedures of the study protocol</li>\n</ul>\n
      • primary_end_points<p>\n <em>Definitive cure</em> - cure at 6 months follow up defined as absence of clinical signs and symptoms of VL at D210 and no requirement for rescue treatment during the trial (e.g. no relapse or initial treatment failure).</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <u><strong>KIMALEL SITE</strong></u></p>\n<p>\n <u><strong>Investigators:</strong></u></p>\n<ul>\n <li>\n Dr. Jane Mbui, MBChB, Mmed Internal Medicine – Principal Investigator</li>\n <li>\n Dr. Simon Njoroge, MBChB, Mmed Pediatrics – Co-Principal Investigator</li>\n</ul>\n<p>\n <strong><u>Site Investigators:</u></strong></p>\n<ul>\n <li>\n Dr. Peter Kioko – Medical Doctor (MBChB)</li>\n <li>\n Jonathan Chebotibin – Study Nurse (KRCHN)</li>\n <li>\n Bernard Kipkemboi Chepkwony - Study Pharmacist (Diploma in Pharmaceutical Technology)</li>\n</ul>\n<p>\n <strong><u>Site Facilities:</u></strong></p>\n<p>\n Kimalel health centre is a Ministry of Health hospital located in rift valley province, Baringo County, Marigat district, Kenya. The Kimalel hospital has a VL treatment centre with a 22 bed ward within the hospital.</p>\n<p>\n Previously, the site was managed by Medicines San Frontiers (MSF) but currently DNDi supports treatment at the kala azar treatment centre in this facility. The Kala Azar treatment centre has the objective to provide access to Diagnostics and Treatment for VL for the surrounding community. The treatment center treats approximately 200 patients/year. DNDi rehabilitated the hospital for clinical trial purposes and purchased an ambulance.</p>\n<p>\n Outpatient registration Desk - As per MOH procedure, all patients received in the clinic are registered in the Outpatient register and given an Outpatient number. The patients then receive a ‘General Outpatient Record’ card which is retained in the hospital as copy of the outpatient records. The outpatient record also becomes source document to record the Past Medical History and will be used for any future visits by the patient. The patient is also given ‘Kimalel Sub-District Hospital Attendance Card’ for future appointments.</p>\n<p>\n Clinical Officer’s Room- All patients are then referred to the Clinical Officer’s room for consultation, diagnosis and treatment. A decision is taken to treat, discharge or admit the patient depending on their medical condition. Patients suspected of Visceral Leishmaniasis have blood taken for Full Hemogram (Complete Blood Count) and PTI (Prothrombin Time Index). The patient is then admitted to the ward pending lab results and further investigation unless the picture from the CBC/PTI is not suggestive of VL. The Clinical Officer’s room serves as the phlebotomy room and initial Vital Signs observation station.</p>\n<p>\n Observation Room – After the Clinical Officer review, the patients is referred to the observation room. As per MOH procedure, all patients admitted are given an in-patient number. Patients with suspected VL will undergo pre-admission observations performed by the nurse. The in-patient file is opened and the patient is then taken to the ward.</p>\n<p>\n Male/Female Ward – After the patient has been registered for admission, they receive an in-patient number and file, patients suspected of VL undergo the full informed consent process. Once the patient has signed the informed consent, the patient receives a CCR number (equivalent to Study Participant number). The patients consented are entered into the screening log. The patient then receives a Study File and may now undergo a Spleen Aspirate for parasitology and inclusion/exclusion procedures as defined in the protocol. If the patient qualifies for the study, he/she is admitted in the ward and treatment commences.</p>\n<p>\n The study site will has the capacity to conduct the screening and safety laboratory tests. These include HIV testing, Hematology and Biochemistry analysis.</p>\n<p>\n  </p>\n<p>\n <u><strong>KACHELIBA SITE</strong></u></p>\n<p>\n <u>Investigators:</u></p>\n<ul>\n <li>\n Dr. Jane Mbui, MBChB, Mmed Internal Medicine – Principal Investigator</li>\n <li>\n Dr. Simon Njoroge, MBChB, Mmed Pediatrics – Co-Principal Investigator</li>\n</ul>\n<p>\n <u>Site Investigators:</u></p>\n<ul>\n <li>\n Mark Riongoita -Clinician (Diploma in clinical medicine and surgery)</li>\n <li>\n Charity Maingi – Study Nurse (KRN, KRM, KRPHN, BSc Nursing, MPH Epidemiology)</li>\n <li>\n Songio Kosgei Kipchirchir - Study Pharmacist (Diploma in Pharmaceutical Technology)</li>\n</ul>\n<p>\n <u>Site Facilities:</u></p>\n<p>\n Kacheliba sub district hospital is a Ministry of Health hospital located in Kacheliba, North Pokot District, West Pokot County, Kenya. The Kacheliba hospital has a VL treatment centre with a 50 bed ward within the hospital. DNDi supports treatment at the kala azar treatment centre in this facility. The Kala azar treatment centre has the objective to provide access to Diagnostics and Treatment for VL for the surrounding community.The treatment centre treats approximately 500 patients/year.</p>\n<p>\n Registration, outpatient clinic and ward: All patients received in the clinic are registered in the outpatient register and given an outpatient number.  All patients are referred to the clinician’s room for consultation, diagnosis and treatment. Patients who are suspected to have VL have blood samples taken for full hemogram (Complete Blood Count) and Prothrombin Time Index (PTI).  Patient is then admitted to the ward pending lab results.   Once the patient is confirmed to have VL and meet the inclusion exclusion criteria, informed consent form will be administered by the nurse or clinical officer in the kala azar treatment room.</p>\n<p>\n Observation room: After obtaining the informed consent, patient’s anthropometric data will be obtained within the kala azar treatment room. This room will also double as a storage area for Case Report Forms and the source documents.  The facility has a kala-azar suspect patient file where all patient information will be recorded.</p>\n<p>\n Male/female ward: Once patient is enrolled in the study, they will be admitted in the ward and treatment commenced.  During the hospitalization period, they will be reviewed by the study staff daily until they are discharged.</p>\n<p>\n The study site has the capacity to conduct the screening and safety laboratory tests. These include HIV testing, Hematology, Biochemistry analysis. The lab was  upgraded prior to the conduct of the previous Miltefosine trial.  New equipment was  installed, validated and commissioned for these purposes.  These equipment are still at site and will be used in this new trial. </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n This trial will be conducted in Kenya, Uganda, Sudan and Ethiopia, which are affected by Visceral Leishmaniasis (VL).  VL does not occur in Switzerland which is the sponsor host country.</p>\n<p>\n Eastern Africa is expected to become the VL region with the highest burden worldwide for global VL control, following significant VL elimination efforts in Southeast Asia.</p>\n<p>\n WHO revised the recommended VL treatment for Eastern Africa in 2010 from sodium stibogluconate (SSG) monotherapy (30 days treatment) to a combination of SSG and PM administered for 17 days, following a phase III trial conducted in the region (WHO, 2010). The efficacy of SSG-PM combination was 91% in the intention to treat population using a complete case analysis, which was non-inferior to a 30-day SSG monotherapy (Musa et al., 2012; Hailu et al., 2010). This new treatment is an improvement over the 30-day SSG monotherapy, but a few important drawbacks and limitations still preclude its general use. Although the treatment regimen is shorter, it still requires 17 days of two separate painful injections, necessitating patients to be hospitalized during the whole treatment period. In addition, there are life-threatening toxicities associated with the use of antimony-based treatments such as SSG. These include cardiotoxicity, hepatotoxicity and pancreatitis.</p>\n<p>\n AmBisome® (liposomal amphotericin B) is used as 2^nd line drug for rescue treatment and for specific target populations such as pregnant women, severe disease or HIV co-infection. The need for cold chain, high cost and the administration by well trained personnel limit the widespread use of AmBisome® in Eastern Africa.</p>\n<p>\n Therefore, there is a need to explore alternatives that are efficacious, safe, ideally of short duration, affordable and suitable to be used in remote areas where VL occurs. In this context, an oral efficacious and safe treatment would be more adapted to field conditions and would allow shorter hospitalization time.</p>\n<p>\n As we wait for the New Chemical Entities, new opportunities with currently available compounds should be assessed to improve on current treatment options, with the main aim to replace the toxic and patient-unfriendly SSG treatment-component.</p>\n
      • other_details_regulatory_notapproved<p>\n National Drug Authority - Uganda</p>\n<p>\n Application date: 7th April 2017</p>\n
      • other_details_regulatory_approved<p>\n None yet</p>\n
      • other_details_regulatory_rejected<p>\n None have rejected the trial so far</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationRecruitment for the entire trial is expected to take 14 - 17 months. Each patients participation in the study will be for approximately 7 months. Therefore the study duration (first patient in to last patient last visit) will be approximately 24 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard of care treatmen
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites2
      • multi_country_listKenya, Uganda, Sudan, Ethiopia
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKacheliba - approx. 15 participants per month\nKimalel - approx. 10 participants per month\nRecruitment for entire trial expected to take 14 - 17 months
      • total_participants_worldwide576
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyAll participants will be patients who require treatment for Visceral Leishmaniasis.\nAny woman of child bearing potential has to consent to use depoprovera contraception in order to be eligible to participate in the trial.\nChildren from 4 years of age upwards will be enrolled into the clinical trial based on consent from their parents. Children aged 12 yrs to < 18 years will give assent to participate in addition to consent from their parent/guardian
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJane
      • investigator1_middle_name
      • investigator1_family_nameMbui
      • investigator1_qualificationMBChB, MMed (Internal Medicine), MSc Epidemiology
      • investigator1_professional_addressCentre for Clinical Research Kenya Medical Research Institute
      • investigator1_telephone+254 20 2722541 ext 3211 (office) +254 722 755358 (mobile)
      • investigator1_emailjmbui@kemri.org
      • organisations_transferred_No
      • number_participantsDue to competitive enrolment between the 4 countries involve, approximately 150 patients, but could be less or more depending on speed of enrolment across the 4 countries.
      • notification
      • approval_date04-10-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n <strong>Protocol Title:</strong> An open-label, Phase lll, randomized controlled multicenter non-inferiority trial to compare efficacy and safety of Miltefosine and paromomycin with sodium stibogluconate and Paromomycin combination for treatment of primary visceral leishmaniasis patients in Eastern Africa</p>\n<p>\n <strong>Institutions and Investigators:</strong></p>\n<ol>\n <li>\n Kenya Medical Research Institute - Dr. Jane Mbui, Dr. Simon Njenga</li>\n <li>\n Kimalel Health Centre: Dr. Peter Kioko</li>\n <li>\n Kacheliba Sub-District Hospital: Mark Riongoita</li>\n</ol>\n<p>\n  </p>\n<p>\n <strong>Sponsor</strong>: Drugs for Neglected Diseases <em>initiative</em> (DNDi), 15 Chemin Louis Dunant, 1202 Geneva, Switzerland</p>\n<p>\n <strong>Protocol Summary:</strong></p>\n<p>\n The current treatment for Kala-azar in East Africa is Sodium Stibogluconate (SSG) with Paromomycin (PM) for 17 days. This treatment requires 2 injections every day for 17 days in the hospital. The injections are painful and can affect the heart, liver, and pancreas. This study is being done to find better treatments that take fewer days, are effective, safer, less painful, affordable and easy for use in remote areas.</p>\n<p>\n This study aims to determine the safety and efficacy (how well a treatment works) of two combination regimens of PM and Miltefosine (MF) as compared to SSG-PM for the treatment of Kala-azar in patients in Eastern Africa.  Miltefosine is taken by mouth while SSG and PM are given by injection.</p>\n<p>\n There will be three treatment groups. Two groups will receive PM+MF combination for 14 days with one of them extending MF until 28 days. A third group will receive SSG and PM combination for 17 days.</p>\n<ul>\n <li>\n Group 1: Paromomycin injection for 14 days combined with Miltefosine by mouth 2 times a day for 14 days</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n Group 2: Paromomycin injection for 14 days combined with Miltefosine by mouth 2 times  a day for 28 days</li>\n</ul>\n<ul>\n <li>\n Group 3: Sodium Stibogluconate injection combined with Paromomycin injection for 17 days\n <ul>\n <li>\n <em>Note: Group 3 is called the control group</em> – it is the current standard treatment for Kala-azar in East Africa</li>\n </ul>\n </li>\n</ul>\n<p>\n  </p>\n<p>\n In this study each patient’s treatment will be allocated randomly by chance, equally between the 3 treatment groups being tested and each patient will know what treatment they will receive.</p>\n<p>\n All patients will get the treatments in the hospital except patients in the group receiving Miltefosine for 28 days who will take the remaining medicines at home after they are discharged when they finish their PM and MF for 14 days.</p>\n<p>\n The study will allow us to compare how the treatments work, know which PM and MF combination is better, how safe the treatments are and how regularly patients take the medicines at home.</p>\n<p>\n <strong>Study population and duration of the study</strong></p>\n<p>\n The target population for this study is patients who are being diagnosed with Kala-azar for the first time and who have never been treated for Kala-azar. These patients will range from 4 to 50 years old. It is important to include children in this study because they are particularly at risk of this disease and contribute to the disease burden in the Eastern African region.</p>\n<p>\n The study will enroll a total of 576 patients in Kenya, Sudan, Ethiopia and Uganda where Kala-azar affects the population. Each of the 3 treatment groups will have 192 patients. There are 6 hospitals involved in the study: Kimalel, and Kacheliba in Kenya; Amudat in Uganda; Gondar in Ethiopia and Dooka and Um El Kheir in Sudan. Participation for each patient in the study will be around 7 months from the day of enrollment until the last study visit. The study itself will last about 2 years from the first patient enrolled until the last patient has finished their last visit and the study is closed.</p>\n<p>\n <strong>Procedures during the study</strong></p>\n<p>\n Each study participant will stay in the hospital for about 2-3 weeks depending on their treatment group. During study participation, the patient will have assessments done before starting the study medication, followed by the treatment period of either 14, 17 or 28 days and 6 months of follow up after completing treatment. During the treatment period, patients will be seen in the clinic on Day 1, 3, 7, 14. Some patients in treatment group 2 will also be seen on day 21 to check the amount of Paramomycin in their blood. After discharge patients will come for follow up visits from home, 28 days after treatment start, 1 month after treatment start and at 6 months after the end of treatment.</p>\n<p>\n The health care workers will closely monitor the safety of the patients throughout the study by checking for any medical illness or any reactions that may or may not be related to the study treatments. If deemed necessary, treatment may be interrupted to ensure the safety of the patient. All safety events will be recorded, followed closely and treated appropriately for resolution of the event.</p>\n<p>\n Patients will have blood collected for measurement of the levels of the Miltefosine in their blood on day 28 and day 56 in order to assess if they have taken their drugs consistently and correctly as recommended.</p>\n<p>\n In Kenya and Sudan, 40 patients (20 children and 20 adults) in treatment groups 1 and 2 will have blood collected for measurement of drug (MF and PM) levels more frequently during the treatment period.</p>\n<p>\n The amount of parasite in the blood and bone marrow or spleen will be checked to assess how well the different treatments work and compare the response with the different treatments. The amount of parasite will also be checked in the follow up period if it is suspected that the patient has had a relapse of disease.</p>\n<p>\n Finally, adherence to MF treatment in an outpatient setting will also be assessed. If it is proven that MF and PM combination works as well as the combination of SSG and PM, the combination of PM and MF is expected to significantly improve treatment safety and to reduce pain, while ensuring low cost and suitability to be used in remote areas.</p>\n
      • implication_results<p>\n <span style=\"font-size: 20pt; font-family: Calibri; color: rgb(86, 87, 85);\">- <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">Efficacy of 91.2% at 6 months follow-up in the MF/PM new treatment is </span></span></span><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><span style=\"color: rgb(86, 87, 85);\">similar to</span><span style=\"color: rgb(86, 87, 85);\"> the efficacy of 91.8% in the SSG/PM arm. Non-inferiority was demonstrated in the Per Protocol analysis with </span><span style=\"color: rgb(86, 87, 85);\">92.0% efficacy in the MF/PM arm vs 91.7% in the SSG/PM arm</span></span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\"><span style=\"color: rgb(86, 87, 85);\">- </span><span style=\"color: rgb(86, 87, 85);\">MF/PM treatment reduces the use of SSG in </span><span style=\"color: rgb(86, 87, 85);\">Kenya. </span><span style=\"color: rgb(86, 87, 85);\">Treatment duration is reduced from 17 days to 14 days and removes one daily injection of SSG</span></span></span></p>\n
      • quantity_importedSSG 700 vial, PM 12,000-amp, MF 10136 tabs
      • quantity_dispensedSSG 331 vial, PM 7171-amp, MF 7245 tabs
      • quantity_destroyed269 Vials of Sodium Stibogluconate (SSG), 4829 amp of Paromomycin (PM) and 2891 tabs of miltefosinsin(MF)
      • quantity_exportedNA
      • balance_site0
      • final_date0000-00-00
      • modified2023-02-10 12:00:24
      • created2017-06-16 09:42:28
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id389
        • application_id612
        • given_nameJane
        • middle_name
        • family_nameMbui
        • qualificationMBChB, MMed (Internal Medicine), MSc Epidemiology
        • professional_addressCentre for Clinical Research Kenya Medical Research Institute
        • telephone+254 20 2722541 ext 3211 (office) +254 722 755358 (mobile)
        • emailjmbui@kemri.org
        • created2017-06-16 10:14:04
        • modified2020-03-03 09:20:44
    • SiteDetail(array)
      • 0(array)
        • id493
        • application_id612
        • county_id30
        • site_nameKimalel Health Centre
        • physical_addressBaringo County, Marigat district, Kenya
        • contact_detailsDr. Kioko - +254710 372 352
        • contact_personDr. Kioko
        • site_capacity(null)
        • misc(null)
        • created2017-06-16 10:14:04
        • modified2020-03-03 09:20:44
        • County(array)
          • id30
          • county_nameBaringo
          • created2012-06-15 10:25:39
          • modified2012-06-15 10:25:39
      • 1(array)
        • id494
        • application_id612
        • county_id24
        • site_nameKacheliba sub-county hospital
        • physical_addressWest Pokot County, North Pokot district, Kacheliba division.
        • contact_detailsMark Riongoita - 0717478314 / 0735870606
        • contact_personMark Riongoita
        • site_capacity(null)
        • misc(null)
        • created2017-06-16 11:27:40
        • modified2020-03-03 09:20:44
        • County(array)
          • id24
          • county_nameWest Pokot
          • created2012-06-15 10:24:52
          • modified2012-06-15 10:24:52
    • Sponsor(array)
      • 0(array)
        • id313
        • application_id612
        • sponsorDrugs for Neglected Diseases Initiative
        • sponsor_typeOthers
        • contact_personGina Ouattara
        • addressTetezi Towers, 3rd Floor, George Padmore Road, Kilimani, P.O. Box, Nairobi, Kenya
        • telephone_number+254 20 3995 000
        • fax_number
        • cell_number+254790203107
        • email_addressgmouattara@dndi.org
        • created2017-06-16 10:14:04
        • modified2020-03-03 09:20:44
  • 3(array)
    • Application(array)
      • id771
      • user_id473
      • trial_status_id4
      • abstract_of_study<p>\n <span style=\"font-size:12px;\">The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travellers’ Diarrhoea (TD) in a deployed setting. In addition the study will explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed United States (US) and United Ki</span>ngdom (UK) military personnel.</p>\n
      • study_title<p align=\"center\">\n <span style=\"font-size:12px;\"><strong>A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial Evaluating Two Dose Regimens of Rifaximin (550 mg daily or 550 mg twice daily) for Chemoprophylaxis Against Travellers’ Diarrhoea (TD) Among Active Duty Deployed U.S. and British Military Personnel (PREVENT TD)</strong></span></p>\n
      • laymans_summary<h1>\n <span style=\"font-size:12px;\">The purpose of this study is to develop proof on the ability of 2 rifaximin medicines used for the prevention of Travellers’ Diarrhoea (TD) for military personnel sent to outer stations for different operations. In addition the study will try to find out the effect of the study medications on intestinal system's composition and antimicrobial resistance, and obtain any new information to help come up with a cost-effective use of medications used in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among military personnel from the United States (US) and United Kingdom (UK).</span></h1>\n<h1>\n  </h1>\n
      • short_titlePREVENT TD
      • protocol_noECCT/19/03/02
      • version_no6
      • date_of_protocol14-11-2016
      • study_drugrifaximin
      • disease_conditionDiarrhoea
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameXIFAXAN
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmargaretkoech@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantMargaret Koech
      • declaration_date108-03-2019
      • declaration_principal_investigatorMAJ Alexander Flynn
      • declaration_date208-03-2019
      • placebo_presentYes
      • study_objectives<h1>\n <span style=\"font-size:14px;\"><strong>OBJECTIVES AND SPECIFIC AIMS</strong></span></h1>\n<ol style=\"list-style-type:upper-roman;\">\n <li>\n <strong>Primary:</strong> To assess the efficacy of 550 mg rifaximin compared with placebo when taken twice daily (BID) or once-daily, by healthy subjects, to prevent TD.</li>\n <li>\n <strong>Secondary</strong>:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Safety of rifaximin when compared to placebo when taken to prevent TD.</li>\n <li>\n As a secondary objective, the efficacy of rifaximin vs. placebo will be evaluated in terms of an expanded series of endpoints (See secondary efficacy endpoints).</li>\n </ol>\n </li>\n <li>\n <strong>Exploratory:</strong>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Quantify the occurrence of rifaximin resistance (primary and acquired) among enteropathogens and commensal flora.</li>\n <li>\n Evaluate effect of rifaximin prophylaxis on the enteric microbiome.</li>\n <li>\n Evaluate the risk and biomarkers of a functional gastrointestinal disorder among subjects with TD compared to those with no TD during surveillance period.</li>\n <li>\n Estimate the efficacy of chemoprophylaxis in preventing TD-associated long-term health outcomes, specifically functional gastrointestinal disorders (FGD) and Reactive Arthritis (ReA).</li>\n <li>\n Evaluate the onset of TD after cessation of prophylaxis among subjects who remain at Country of Deployment (COD) beyond maximal prophylaxis period.</li>\n <li>\n Obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis strategy.</li>\n <li>\n Evaluate comparative efficacy of rifaximin in various geographic regions.</li>\n </ol>\n </li>\n</ol>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<ol style=\"list-style-type:upper-roman;\">\n <li value=\"4\">\n <strong>Secondary Endpoints (Efficacy):</strong>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Secondary efficacy endpoints over the period of prophylaxis will include the proportion of subjects in each treatment group:\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n With TD</li>\n <li>\n With mild diarrhea</li>\n <li>\n With treated diarrhoea (TD and mild diarrhoea)</li>\n <li>\n With TD associated with isolation of a pathogen and pathogen type (invasive vs. enterotoxigenic <em>Escherichia coli</em> (ETEC) or other non-invasive pathogen-(only among subjects with appropriate samples to perform evaluation)</li>\n <li>\n Total diarrhoeal days</li>\n <li>\n Work days and performance loss due to diarrhoea, and</li>\n <li>\n Comparison of incidence of TD (TD event number and person-time risk)</li>\n </ol>\n </li>\n </ol>\n </li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. A MODREC approved informed consent form is signed and dated.</div>\n<div>\n 2. Subject is at least 18 years of age.</div>\n<div>\n 3. Subject’s duration of prophylaxis will be at least 2 weeks.</div>\n<div>\n 4. Subject is capable of and willing to comply with all study procedures and available for the end of</div>\n<div>\n study visits and sample collection.</div>\n<div>\n 5. Women: Non-breast-feeding and negative urine/serum pregnancy test with understanding</div>\n<div>\n (through informed consent process) to avoid pregnancy while on study drug. Sole reliance on OCPs</div>\n<div>\n for birth control will not be recommended. Should an individual have a documented surgical</div>\n<div>\n sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes</div>\n<div>\n pregnant during the study, the principal investigator will notify the study research monitor and the</div>\n<div>\n MODREC/IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements</div>\n<div>\n for US and UK personnel.</div>\n
      • principal_exclusion_criteria<div>\n 1. Subject has hypersensitivity or allergy to rifaximin or rifampicin.</div>\n<div>\n 2. Subject has a concomitant disease or condition that could interfere with, or for which treatment</div>\n<div>\n could interfere with, the conduct of the study, or could in the opinion of the investigator increase the</div>\n<div>\n risk of AEs during the subject’s participation in the study</div>\n<div>\n 3. Subject is currently taking theophylline, digoxin, or warfarin.</div>\n<div>\n 4. Planned deployment length less than 6 weeks duration.</div>\n
      • primary_end_points<div>\n The primary objective of the study is to assess the efficacy of 550 mg rifaximin compared with</div>\n<div>\n placebo when taken twice daily (BID) or once-daily, by healthy subjects, to prevent TD.</div>\n<div>\n This will be assessed by review of the symptom memory aid with a study investigator to assess if</div>\n<div>\n travellers diarrhoea (defined in the study as >2 episodes of loose or liquid stool within 24 hours or 2</div>\n<div>\n episodes + associated sypmtom(s).</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Study site</div>\n<div>\n The main study site will be the Medical Centre at LAB-E, British Army Training Unit, Kenya, in Nanyuki.</div>\n<div>\n This is a purpose built Medical Centre which supports British troops exercising in Kenya. It has full</div>\n<div>\n facilities for safe recruitment of subjects, and emergency treatment should this be required. It is</div>\n<div>\n staffed by 2 permanent Medical Officers. This will be augmented by the study team while the study</div>\n<div>\n is recruiting. Previously it has been used as a site for a large RCT which recruited over 150 subjects. It</div>\n<div>\n has clinical areas for recruitment of subjects, a monitored temperature secure pharmacy, facilities for</div>\n<div>\n secure storage of clinical records relating to subjects, resusitation facilties and equipment (and 24hour</div>\n<div>\n on-call medical personnel), and a clinical laboratory will be set up there.</div>\n<div>\n Personnel & related infrastructure</div>\n<div>\n The study team will be led by Major (Dr) Dan Burns and Col (Dr) Patrick Connor. Major Dan Burns</div>\n<div>\n has experience of being site PI for a large international RCT. Col Patrick Connor has led UK coordination</div>\n<div>\n of a large international RCT recruiting several hundred subjects. Both are GCP trained. In</div>\n<div>\n addition there will be a Kenya PI based out of USAMRU-K who will help liaise with the Kenya specific</div>\n<div>\n regulatory aspects of the trial.</div>\n<div>\n The study team consists of suitable qualified Medical Officers, nurses, and pharmacy support which</div>\n<div>\n will deploy to Kenya when the study is actively recruiting subjects. These individuals all hold current</div>\n<div>\n UK professional qualifications, are GCP trained and have specific training on the study protocol.</div>\n<div>\n An on-site pharmacy technician will ensure that Investigative Medical Product is stored, transported</div>\n<div>\n and dispensed safely and securely. They will be supported by a UK GCP trained pharmacist, Stephan</div>\n<div>\n D'Abreu-Hayling.</div>\n<div>\n A UK qualified biomedical scientist will oversee transport, storage and processing of clinical specimens.</div>\n<div>\n They will set up an on-site clinical laboratory which will perform initial processing and storing of</div>\n<div>\n specimens. Specimens (blood and stool) will be transported to the US by assured cold chain for</div>\n<div>\n further microbiological and other testing via the USAMRU-K laboratory. This process has previously</div>\n<div>\n been used successfully for clinical and research specimens.</div>\n<div>\n Study monitoring will be performed to assure the sponsor that the study is being conducted safely</div>\n<div>\n and in accordance with GCP principles and the protocol. David Mulvanney, an experience Nursing</div>\n<div>\n Officer, with GCP training and specific protocol and monitoring training will independently perform this</div>\n<div>\n function from the UK, supported will locally by the UK Military Senior Medical Officer, Kenya, and his</div>\n<div>\n team.</div>\n
      • other_details_explanation<div>\n The trial is testing prophylaxis against travellers' diarrhoea in UK soldiers. Kenya is a well established location for UK soldiers exercising</div>\n<div>\n overseas at the British Army Training Unit, Kenya. It means there are predictable numbers of soldiers deploying overseas to act as subjects</div>\n<div>\n for this travel trial, with data from previous studies showing a predictable rate of travellers diarrhoea (allowing power calculations).</div>\n<div>\n The applicant and sponsor are UK based, but will only recruit UK soldiers as subjects. Due to the nature of the trial we cannot conduct it in</div>\n<div>\n the UK, and Kenya is the best location for this research as outlined above, but also because of previous trials conducted, and establsihed</div>\n<div>\n connections with US Military colleagues at USAMRD-K.</div>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<div>\n Ministry of Defence Research Ethics Committee - UK Ethics Approval granted April 2017.</div>\n<div>\n Medicines & Healthcare Regulatory Agency - UK Competent Authority Approval granted April 2017.</div>\n<div>\n Uniformed Services University of the Health Sciences (USA) Instituitional Review Board Approval granted November 2014.</div>\n<div>\n Food and Drug Administration, exemption granted date XXXXXXX</div>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo; 550mg rifaximin
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaNyati Barracks, British Army Training Unit, Kenya
      • single_site_physical_addressNyati Barracks, Nanyuki, British Army Training Unit, Kenya, BFPO 680
      • single_site_contact_personMajor Dan Burns
      • single_site_telephone+447872966105
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listUS and Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site235
      • total_participants_worldwide375
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLillian
      • investigator1_middle_name
      • investigator1_family_nameMusila
      • investigator1_qualificationPhD
      • investigator1_professional_address606, 00621, Village market, Nairobi, Kenya
      • investigator1_telephone+254-728-817872
      • investigator1_emaillillian.musila@usamru-k.org
      • organisations_transferred_No
      • number_participants235
      • notification<p>\n None</p>\n
      • approval_date10-06-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The purpose of this study was to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travellers’ Diarrhoea (TD) in a deployed setting. In addition the study would explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed United States (US) and United Kingdom (UK) military personnel.</p>\n<p>\n  </p>\n
      • implication_results<p>\n  "This study's purpose was to develop evidence on use of 2 chemoprophylaxis regimens for the prevention of Travellers’ Diarrhoea (TD) in a deployed setting, as well as explore its effect on microbial flora and antimicrobial resistance. Its completion would essentially inform on the cost-effectiveness of use of chemoprophylaxis in prevention of TD as opposed to treatment of the illness in a deployed setting. This information would be used to develop management guidelines for TD among deployed United States (US) and United Kingdom (UK) military personnel.</p>\n<p>\n We however have no results to share on this outcome, since we did not get to participate in this trial due to the expiry of the sponsor's timeline requirements which we were unable to meet".</p>\n
      • quantity_importedN/A
      • quantity_dispensedN/A
      • quantity_destroyedN/A
      • quantity_exportedN/A
      • balance_siteN/A
      • final_date0000-00-00
      • modified2020-10-23 09:37:01
      • created2019-03-07 14:28:40
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id481
        • application_id771
        • given_nameFlynn
        • middle_name
        • family_nameAlexander
        • qualificationPhD
        • professional_address1357, 20200, Kericho, Kenya
        • telephone+254-705-251687
        • emailflynn.alexander@usamru-k.org
        • created2019-03-07 14:40:02
        • modified2020-02-27 08:14:14
    • SiteDetail(array)
      • 0(array)
        • id627
        • application_id771
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-03-07 14:40:02
        • modified2020-02-27 08:14:14
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id375
        • application_id771
        • sponsorMilitary Infectious Diseases Research Program (MIDRP)
        • sponsor_typeResearch Institution
        • contact_personCDR Ramiro Gutierrez
        • addressNavy Medical Research Center
        • telephone_number+1 301-319-3193
        • fax_number
        • cell_number+1 301-319-3193
        • email_addressramiro.l.gutierrez.mil@mail.mil
        • created2019-03-07 14:40:02
        • modified2020-02-27 08:14:14
  • 4(array)
    • Application(array)
      • id92
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n Areas of high HIV prevalence and intense malaria transmission significantly overlap especially sub-Saharan Africa where a majority of HIV-infected individuals also live in malaria-endemic regions.  Sub-Saharan Africa remains the region most heavily affected by HIV, accounting for 67% of all people living with HIV and 75% of AIDS deaths in 2007.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa.                                           </p>\n<p>\n Recent studies have indicated that the interaction between HIV and malaria infection is bi-directional and synergistic. HIV-infected persons are at increased risk for clinical malaria and potential malaria treatment failure. In addition to an apparent increased vulnerability to malaria parasitemia in HIV-infected adults living in malaria endemic regions, malaria may also enhance HIV replication.  Evidence suggests that HIV/malaria coinfection is associated with increased HIV viral load and may therefore impact negatively upon HIV disease progression and/or increase the risk of HIV transmission.  In Kenya, the burden of both HIV and malaria remains significant.  However, while clinic programs and research studies are ongoing targeting HIV and malaria separately, very little if any research is ongoing focusing upon the HIV/malaria co-infection.</p>\n<p>\n Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as PIs used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs.</p>\n<p>\n This study will test the superiority of LPV/r-based ART compared with nNRTI-based ART clearance of <em>Pf</em> SCP.  The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia on three consecutive occasions within a 24-hour period. HIV-infected participants ≥18 years with CD4+ counts >200 and <u><</u>350 cells/mm³ who will be starting ART and have <em>Pf</em> SCP will be enrolled and randomized to receive either LPV/r or nNRTI-based ART for 15 days. After the 15 day <em>Pf</em> SCP clearance evaluation, all participants will receive nNRTI-based ART plus TMP/SMX prophylaxis to take for 15 days.</p>\n<p>\n The Kericho site will recruit about 20-30 participants, in part dependent upon timing of protocol activation compared to the other 5 sites in this international, multi-center study.  Recruitment will be focused at the Kericho District Hospital HIV clinic.  Nearby health and HIV Testing and Counseling (HTC) facilities under the KEMRI/WRP PEPFAR program will also be utilized.  Participants will be followed for 30 days. The site accrual rate is estimated to be 2-3 participants per month; hence estimated duration of accrual is about 12 months.</p>\n<p>\n  </p>\n<p>\n If PIs are shown to have marked benefit in clearance of subclinical malaria, such information would be informative to both clinical researchers (i.e. KEMRI) in considering future HIV/malaria infection research as well as policy stakeholders (i.e. Ministry of Health) in considering optimal treatment and prevention initiatives.</p>\n
      • study_title<p align=\"center\">\n  </p>\n<p style=\"text-align: justify;\">\n <strong>An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of </strong></p>\n<p style=\"text-align: justify;\">\n <strong><em>Plasmodium falciparum</em></strong><strong> Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <u><</u>350 cells/mm³</strong> .</p>\n
      • laymans_summary<p>\n The areas that has highest problems of HIV infection, also experiences the biggest burden of malaria. Sub-Saharan Africa remains the region most heavily affected by HIV.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa. Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as those used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs</p>\n
      • short_titleHIV-Malaria Study_A5297
      • protocol_noECCT/13/04/03
      • version_noVersion 1.0
      • date_of_protocol29-02-2012
      • study_drugefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • disease_conditionHIV and Malaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKEMRI Walter Reed Project. P.O. Box 1357-20200 Kericho
      • declaration_date108-04-2013
      • declaration_principal_investigatorDr Josphat Kiprop Kosgei, Principal Investigator.
      • declaration_date208-04-2013
      • placebo_presentNo
      • study_objectives<div>\n Primary Objective</div>\n<div>\n To compare the proportions of Pf SCP clearance between LPV/r-based and</div>\n<div>\n nNRTI based ART in participants after 15 days of therapy (Step 1).</div>\n<div>\n 1.4 Secondary Objectives</div>\n<div>\n 1.4.1 To compare time to Pf SCP clearance in participants with Pf SCP who have</div>\n<div>\n received 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.2 To compare Pf parasite densities in participants with Pf SCP who have received</div>\n<div>\n 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.3 To estimate changes in Pf parasite densities from day 1 to day 30 in four cohorts:</div>\n<div>\n (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2)</div>\n<div>\n randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3)</div>\n
      • principal_inclusion_criteria<p style=\"margin-left: 1in;\">\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: The term “licensed” refers to a US FDA-approved kit, which is required for all US sites and recommended for non-US ones. For non-US sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within that country and validated internally is acceptable.</p>\n<p style=\"margin-left: 1.5in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n WHO (World Health Organization) and CDC (Center for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n CD4+ count > 200 and <u><</u> 350 cells/mm³ obtained within 30 days prior to study entry at a DAIDS-approved laboratory.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n <em>Pf</em> SCP confirmed in a laboratory approved to conduct parasitemia microscopy.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: <em>Pf</em> SCP will be defined as meeting all three of the following criteria within 72 hours prior to study entry:</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n Microscopy confirmed parasitemia (see section 6.3.6 and the A5297 Manual of Procedures [MOPS])</p>\n<p style=\"margin-left: 1.6in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n An oral temperature <u><</u> 37.5^°C temperature</p>\n
      • principal_exclusion_criteria<p>\n Previous history or current use of ART. </p>\n<p>\n  </p>\n<p>\n Single dose NVP or dual therapies used for PMTCT within 2 years prior to entry.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Use of any medication with antimalarial activity, including TMP/SMX (see list of prohibited medications in the A5297 MOPS), within 14 days prior to study entry. </p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Confirmed or clinically suspected OIs (including but not limited to tuberculosis, clinical malaria, <em>PCP</em>), or other pulmonary or gastrointestinal infections for which potential participants did not complete treatment more than 30 days prior to enrollment or have signs and symptoms during screening.</p>\n
      • primary_end_points<p>\n The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia defined as < 10 parasites/µL on three consecutive occasions within a 24-hour period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyProof of Concept
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<h1>\n 1SITE INVESTIGATORS AND CONTACT INFORMATION</h1>\n<p>\n  </p>\n<p>\n <strong>A) Site Principal Investigator</strong></p>\n<p>\n Dr Josphat K Kosgei, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 729 110122</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: josphat.kosgei@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>B) Associate Investigators</strong></p>\n<p>\n Dr Fredrick K Kirui, MBBS, MPH, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531 373</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">fredrick.kirui@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n Dr Deborah C Langat, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 714 059596</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">deborah.langat@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Kathleen C. Rono, MBChB, MPH & TM</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">krono@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Lucy Koech, MBChB,</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 719 193275</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">lucy.</a>koech@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Fredrick K. Sawe, MBChB, MMED</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 724 255623</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">fsawe@wrp-kch.org, fsawe@hivresearch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Douglas N. Shaffer, MD, MHS</p>\n<p>\n United States Army Medical Research Unit-Kenya</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546</p>\n<p>\n  </p>\n<p>\n <strong>C) Pharmacist</strong></p>\n<p>\n Dr. Noah K. Tarus, B Pharm, MSc</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 30388</p>\n<p>\n Mobile: +254 713 603222</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ntarus@wrp-kch.org\">noah.tarus@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>D) Laboratory Director</strong></p>\n<p>\n Dr Kibet Shikuku, MBChB, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555537</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">kibet.shikuku@usamru-k.org</a></p>\n<p>\n <strong>E) Data Manager</strong></p>\n<p>\n Ignatius Kiptoo</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531375</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">ignatius.kiptoo@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>F) Study Coordinator</strong></p>\n<p>\n Hellen Ngeno, BSN</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 713 603225</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:hngeno@wrp-kch.org\">hngeno@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>G) Local DoD Research  Monitor</strong></p>\n<p>\n <u>Primary DoD Research Monitor</u></p>\n<p>\n  </p>\n<p>\n Dr. Appolonia Aoko, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 715 551234</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:aaoko@wrp-kch.org\">aaoko@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Alternate DoD Research Monitor</p>\n<p>\n  </p>\n<p>\n Dr. Jonah Maswai, MBChB, MPH</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 716 430271</p>\n
      • other_details_explanation<p>\n Kenya has a high prevalence of both HIV and Malaria, which is a requirement of the study.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (KEMRI) Ethical Research Committee. Approval date 26 March 2013. This is for Kericho site only.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable.</p>\n
      • estimated_durationOne year
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNNRTI arm
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites2
      • multi_country_listKenya, Botswana, Malawi, India
      • data_monitoring_committeeYes
      • total_enrolment_per_site20-30
      • total_participants_worldwide52
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid
      • investigator1_middle_nameC.
      • investigator1_family_nameWekulo
      • investigator1_qualificationBScN
      • investigator1_professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
      • investigator1_telephone254729110146
      • investigator1_emaildavid.wekulo@usamru-k.org
      • organisations_transferred_Yes
      • number_participants20-30
      • notification
      • approval_date26-03-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to</div>\n<div>\n test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to nonnucleoside reverse</div>\n<div>\n transcriptase (nNRTI)-based ART for clearance of Plasmodium falciparum (Pf) subclinical parasitemia (SCP).</div>\n<div>\n Participants were followed for 30 days in order to evaluate parasitemia clearance, Pf parasitemia, gametocytemia,</div>\n<div>\n and plasmepsin sequencing. Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and</div>\n<div>\n three times for day 15 and day 30.</div>\n<div>\n Fifty-two participants (26 per arm) enrolled between January 10, 2014 and May 20, 2016 with 46 (88%) from two</div>\n<div>\n sites in Kenya. Fifty-one participants completed the primary outcome (Step 1) visit, and 49 completed the protocol</div>\n<div>\n as specified. The study population was mostly male (67%) with a median age of 31 (Q1, Q3=24, 39) years. The</div>\n<div>\n median baseline CD4 count was 324 cells/mm3 (259, 404) and median baseline log10 (HIV-1 RNA) was 5.18</div>\n<div>\n copies/mL (4.60, 5.71). The median baseline parasite density was 2.66 log10 parasites/μL (1.92, 3.35) (Table 1).</div>\n<div>\n For the primary outcome, there was no statistically significant difference in clearance between the LPV/r-based</div>\n<div>\n (n=6, 23%) and nNRTI-based (7, 27%) ART arms (Table 2). Sensitivity analyses were conducted around missing data:</div>\n<div>\n one where missing data were assumed to have cleared and one where missing data were excluded. Sensitivity</div>\n<div>\n analyses were also conducted using less stringent definitions of clearance: one where participants were considered</div>\n<div>\n cleared if any 2 of 3 samples had <10 estimated parasites/μL at day 15 by qRT-PCR and one where participants</div>\n<div>\n were considered cleared if any 1 of 3 samples had < 10 parasites/μL at day 15 by qRT-PCR. In all sensitivity</div>\n<div>\n analyses, the difference in clearance between the treatment arms remained non-significant.</div>\n<div>\n Secondary objective analyses included time-to–Pf parasite clearance, between-arm parasite densities over time,</div>\n<div>\n and safety outcomes. No statistically significant differences in time-to-Pf 9 parasite clearance were observed</div>\n<div>\n between arms (P=0.80, Figure 2). Mean Pf parasite densities through the 30-day study window were examined</div>\n<div>\n (Figure 3). While overall, a trend was observed in decreasing Pf parasite densities in both arms throughout the</div>\n<div>\n study, there was no difference between the two treatment arms during days 1-15 (LPV/r Arm median = -0.61 [Q1,</div>\n<div>\n Q3 = -1.78,0.00] and nNRTI Arm -0.46 [-1.31,0.41]) or days 15-30 (LPV/r Arm -1.04 [-2.39,-0.67] and nNRTI Arm -</div>\n<div>\n 1.40 [-2.51,-0.52]). Overall, Pf parasite density decreased between entry and day 30 (-2.36 [-3.46,-0.94]); at the</div>\n<div>\n same time median CD4 counts increased (101 cells/mm3) and median log10 HIV RNA decreased (-2.48 copies/mL)</div>\n<div>\n with no significant between arm differences.</div>\n<div>\n During the study period, there were few adverse events with no hospitalizations. Three cases of uncomplicated,</div>\n<div>\n Grade 2 clinical malaria (LPV/r Arm n=2, nNRTI Arm n=1) occurred during Step 1, and all received SOC</div>\n<div>\n artemether/lumefantrine. One participant in both treatment arms experienced Grade 2 anemia (n=2).</div>\n<div>\n The Study’s results did not find a statistically significant difference in parasite clearance rates nor in time-toparasite</div>\n<div>\n clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the proof-of-concept RCT of</div>\n<div>\n HIV-infected adults beginning first-line ART with Pf SCP is the first direct comparison between a PI (LPV/r) and</div>\n<div>\n nNRTI.</div>\n
      • implication_results<div>\n Yes, from the Primary Manuscript:</div>\n<div>\n  The Study’s results did not find a statistically significant difference in parasite clearance rates</div>\n<div>\n nor in time-to-parasite clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the</div>\n<div>\n proof-of-concept RCT of HIV-infected adults beginning first-line ART with Pf SCP is the first direct</div>\n<div>\n comparison between a PI (LPV/r) and nNRTI.</div>\n<div>\n  The Study provides a unique cohort testing the clinical impact of PIs in a setting without and with</div>\n<div>\n TMP/SMX. While participants had CD4 counts >200 given requirements for TMP/SMX in people with lower</div>\n<div>\n CD4 counts, the Study observed no complicated malaria, PCP, or diarrheal disease.</div>\n<div>\n  Three cases of uncomplicated malaria (parasitemia and fever) during the first 15 days in the absence of</div>\n<div>\n TMP/SMX. This likely reflects fluctuations in SCP in the absence of TMP/SMX and occasional fever</div>\n<div>\n threshold densities being passed.</div>\n<div>\n  This Study also provides unique opportunity for further investigation into parasite and gametocyte life</div>\n<div>\n cycles and kinetics.</div>\n
      • quantity_importedFind attached product accountability documents
      • quantity_dispensedFind attached product accountability documents
      • quantity_destroyedFind attached product accountability documents
      • quantity_exportedFind attached product accountability documents
      • balance_siteFind attached product accountability documents
      • final_date0000-00-00
      • modified2025-02-25 13:18:04
      • created2013-04-04 14:58:19
      • total_sites(null)
      • ecitizen_invoice(null)
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      • 0(array)
        • id60
        • application_id92
        • given_nameJosphat
        • middle_nameK.
        • family_nameKosgei
        • qualificationMBChB
        • professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
        • telephone254729110122
        • emailjosphat.kosgei@usamru-k.org
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
    • SiteDetail(array)
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        • id80
        • application_id92
        • county_id35
        • site_nameKemri Walter Reed Project-Kericho
        • physical_addressHospital road
        • contact_detailsP.O. Box 1357-20200
        • contact_personJosphat Kosgei
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id83
        • application_id92
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressMoi Teaching Referral Hospital Building, Nandi Road, Eldoret, Kenya
        • contact_detailsP.O. Box 4604 - 30100 Kenya Tel:254-53 2060850
        • contact_personRonald Kibet
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 17:36:47
        • modified2020-03-17 12:04:08
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id46
        • application_id92
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personBeverly Alston-Smith, MD
        • address6700 B Rockledge Drive, Room 5109 Bethesda, MD 20892-7605
        • telephone_number301-435-3773
        • fax_number301-480-4582
        • cell_number301-435-3773
        • email_addressbalston@niaid.nih.gov
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
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PHP Environment

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      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php